Senior Clinical Research Associate

This is a fully remote position, open to applicants in California.

📋 Description

• Propel AbbVie’s clinical research pipeline while supporting groundbreaking medicines and solutions.

• Act as the main sponsor liaison for investigative sites.

• Collaborate with study teams, internal R&D partners, investigators, and site personnel.

• Align, train, and inspire site staff and principal investigators on trial objectives, protocols, and patient treatment principles.

• Mentor and assist junior Clinical Research Associates (CRAs) and facilitate local onboarding.

• Conduct site evaluations, site training, routine onsite and offsite monitoring, and site closure assessments.

• Ensure adherence to protocols, monitoring plans, regulations, GCP, ICH Guidelines, SOPs, and quality standards.

• Tailor site engagement strategies and monitor progress and impact.

• Support recruitment and retention strategies based on the patient disease journey.

• Carry out continuous risk assessments in collaboration with the Central Monitoring team.

• Address site risk signals and implement preventative and corrective action plans.

• Identify, assess, and recommend investigators and clinical sites.

• Ensure data integrity, prompt data submissions, and proper safety-event reporting and follow-up.

• Maintain readiness for audits and regulatory inspections.

• Oversee investigator payments in accordance with contractual obligations.

• Participate in or lead global and local task forces and initiatives.

• Undertake additional tasks as assigned by the manager.

⛳️ Requirements

• Relevant tertiary qualification in a health-related field (e.g., Medical, Scientific, Pharmacy, Nursing) preferred.

• At least 3 years of clinically related experience.

• A minimum of 2 years preferably in independent clinical research monitoring of investigational drug or device trials.

• Familiarity with risk-based monitoring, both onsite and offsite.

• Understanding of therapeutic area indications and scientific concepts pertinent to clinical trials.

• Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and relevant policies.

• Advanced communication and collaboration skills across functions.

• Exceptional planning and organizational abilities.

• Capability to work efficiently in a dynamic environment with competing projects and deadlines.

• Proficient in leveraging technology, tools, and resources for customer-focused site support.

• Excellent written, verbal, active listening, and presentation skills.

• Ability to build and maintain site relationships and trusted partnerships.

• Competence to independently resolve clinical site issues using functional expertise, critical thinking, and judgment.

• Demonstrates integrity in line with AbbVie’s code of business conduct and leadership values.

• Self-driven and focused on achieving timely, quality outcomes.

• Willingness to travel 75% of the time.

🏝️ Benefits

• Paid time off (vacation, holidays, sick leave).

• Medical, dental, and vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Option for remote work.